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510(k) K862381

FUTUREMED ECG SYSTEM 500 by Futuremed Div. of Future Impex Corp. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1986
Date Received
June 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Futuremed Div. of Future Impex Corp.

  • K933511 — UPGRADED SPIROMETER ST-90 (February 10, 1994)
  • K933220 — SELECTOR SL 01 (November 24, 1993)
  • K933222 — AUDIOMETER DA 323 (November 1, 1993)
  • K903017 — MEGA-TENS DUAL CHANNEL T.E.N.S. (October 26, 1990)
  • K901308 — SPIRO ANALYZER MODEL ST 250 (July 23, 1990)
  • K884972 — TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR (July 27, 1989)
  • K871421 — MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT (January 22, 1988)
  • K873817 — SPIRO ANALYZER ST-300 (December 2, 1987)
  • K872044 — CARBON ELECTRODE (July 16, 1987)
  • K871913 — CONDUCTIVITY GEL (July 15, 1987)

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  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)